Ali 2009.

Methods	Randomized controlled trial carried out in Aligarh, India
Participants	Number of infants: 114 Inclusion criteria: hemodynamically stable infants delivered by vaginal route with birthweight between 1200 and 1800 g Exclusion criteria: neonates delivered by cesarean section, major life‐threatening congenital malformations, severe perinatal complications, parental refusal of KMC intervention Infant stabilization status at trial entry: stabilized Infant age and weight at trial entry: Mean age at recruitment was 4.7 ± 2.9 and 4.8 ± 2.4 days, and mean weight was 1607 ± 211 and 1615 ± 179 g, for KMC and control infants, respectively
Interventions	KMC group: SSC between the mother's breasts in an upright position. Infants were dressed with a cap, socks, and a diaper and were supported at the bottom with a sling/binder. The duration of KMC during hospital stay was 6.3 ± 1.5 hours (range, 4 to 12) per day, and KMC was given for a period of 25.7 ± 6.9 (range, 15 to 43) days after enrollment in the study (n = 58) Control group: Infants were kept in radiant warmers or open cots in warm rooms (n = 56) In both groups, mothers were allowed to handle their babies at any hour of the day and to breastfeed them by nasogastric tube, by paladai, or directly. Babies in both groups were provided with vitamins and mineral supplementation Level of care: NICU of a tertiary care hospital Human resources: doctors and nurses Criteria for infant discharge from the hospital: weight gain for ≥ 3 consecutive days, no overt illness, no intravenous medications, exclusive breastfeeding Scheme for follow‐up of infants after discharge: weekly until 40 weeks' postmenstrual age, fortnightly until 3 months' corrected age, and monthly thereafter until 6 months' corrected age
Outcomes	Duration of hospital stay, weight gain, head circumference, length, exclusive breastfeeding, nosocomial sepsis, hypothermia, mild/moderate infection, severe infection, mortality
Notes	81% of LBW infants met eligibility criteria
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomization technique
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	10 infants (8.8%) lost at 40 weeks' corrected gestational age follow‐up (KMC 4, control 6), 21 (18.4%) lost at 3 months' corrected age (KMC 10, control 11), and 39 (34.2%) lost at 6 months' corrected age (KMC 19, control 20)
Selective reporting (reporting bias)	High risk	Non‐significant results such as infant mortality and weight, length, and head circumference at discharge and follow‐up (secondary outcomes listed in Methods) mentioned but not reported adequately
Other bias	High risk	Use of blocked randomization, which could make possible prediction of future assignments in an unblinded trial when assignments are revealed, subsequently to the person recruiting into the trial